At CPhI WW 2019, SGD Pharma will be launching the first application to identify non-compliances in moulded glass bottles intended for the pharmaceutical industry.
Resulting from a development project between SGD Pharma Quality and Marketing departments, this new digital tool makes it possible to identify non-compliances that may be discovered during an incoming inspection or during on-line inspection at client’s side.
Available for free from the Apple Store and the Play Store, it only takes a few clicks for users to create their account and have unlimited access to a 2D visual compilation of the most frequently encountered forms of non-compliance. Users can refine their searches by administration method (parenteral, oral or nasal), by location or non-compliance types corresponding to various effects on the patients or on filling lines (critical, major or cosmetic). Once a non-compliance has been identified, the user then accesses a dedicated page including a visual, a definition, the type of non-compliance and its associated acceptable quality level (AQL) in conjunction with the international standard ISO 2859-1. As an added benefit, the SGD Pharma standards are then cross-referenced with the two quality benchmarks recognised and accepted by the Pharmaceutical industry: technical report 43 from the Parenteral Drug Association (PDA) and the list of moulded glass container noncompliances from Edito-Cantor-Verlag (ECV).
According to Quentin Ritter, Quality Project Manager at SGD Pharma: “This application project was initiated in response to our customers’ increasing demand for glass non-conformities training. It is crucial for them to be able to identify and recognise non-conformities quickly in order to improve inspection processes and make the right decision.”
"The mission of SGD Pharma,” adds Emmanuel Lepitre, Head of Development and Quality, “is to improve safety for the end-user. SGD Pharma App answers to the growing zero-tolerance trend, including cosmetic quality, by hospital staff. With this application, open to all professionals in the industry, designed upstream with its customers in mind, SGD Pharma aims to support the Pharmaceutical Industry to protect patient health."